Inhalation of small capsule pieces through an inhaler is not harmful

04-04-2023

Puncturing powder capsules for inhalation may cause small capsule pieces to break loose. Capsule pieces that are small enough to pass through the filter are sometimes inhaled when using the inhaler.

For some inhalers, the active ingredients for asthma or COPD are stored in capsules. These capsules have to be perforated by the inhaler. The active ingredient is then administered through inhalation. The Netherlands Pharmacovigilance Centre Lareb received twenty-three reports of capsule pieces breaking loose after being punctured.

The capsules are harmless
In case the capsule splinters, it is harmless to inhale the full dose. The reports received by the Netherlands Pharmacovigilance Centre Lareb show that concerns were raised among users of inhalers about inhaling capsule slivers. The capsules are made of excipients that are harmless after inhalation, such as gelatin or hypromellose. Furthermore, the capsule pieces are too large in size to reach the lungs and end up in the mouth or throat after inhalation. Subsequent ingestion of capsule pieces is safe.

Correct storage conditions reduce the risk of capsules splintering
Store the capsules correctly to prevent splintering. Inhalation capsules should be stored in their original packaging, at room temperature and with normal humidity. Do not store the capsules in places directly exposed to sunlight.

The Netherlands Pharmacovigilance Centre Lareb and Voorkomen Medicatie-Incidenten (VMI) are raising awareness about correctly storing inhalation capsules and the importance of adequate inhalation instructions through a practice sting.

Read more about the recommendations here.